Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-03-25

Brief Summary

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The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.

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Detailed Description

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A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.

Conditions

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Tertiary Dentine Indirect Pulp Capping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 3 arm clinical trial. All selected first permanent molars will be randomly equally allocated into three groups according to capping material used.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).

Study Groups

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Silver diamine fluoride/ potassium iodide group

Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia

Group Type EXPERIMENTAL

Silver diamine fluoride/ potassium iodide

Intervention Type DRUG

Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.

Silver diamine fluoride group

Advantage arrest TM, Elevate Oral Care, USA

Group Type EXPERIMENTAL

Silver diamine fluoride

Intervention Type DRUG

Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.

Resin modified glass ionomer cement group

Riva light cure, SDI, Bayswater, Australia

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer cement

Intervention Type DRUG

Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.

Interventions

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Silver diamine fluoride/ potassium iodide

Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.

Intervention Type DRUG

Silver diamine fluoride

Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.

Intervention Type DRUG

Resin modified glass ionomer cement

Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.

Intervention Type DRUG

Other Intervention Names

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SDF/KI SDF RMGIC

Eligibility Criteria

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Inclusion Criteria

For children:

1. Children who are generally healthy.
2. Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
3. Parents signed informed consent.

For first permanent molars:

1. Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007)
2. Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
3. Immature with open apex as revealed by periapical X-ray.

Exclusion Criteria

For children:

1. Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
2. Children unable to return for recall visits.

For first permanent molars:

1. Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
2. Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
3. Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No